WO1995016406A1 - Prothese pour greffe endovasculaire et procede d'implantation - Google Patents

Prothese pour greffe endovasculaire et procede d'implantation Download PDF

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Publication number
WO1995016406A1
WO1995016406A1 PCT/DK1994/000468 DK9400468W WO9516406A1 WO 1995016406 A1 WO1995016406 A1 WO 1995016406A1 DK 9400468 W DK9400468 W DK 9400468W WO 9516406 A1 WO9516406 A1 WO 9516406A1
Authority
WO
WIPO (PCT)
Prior art keywords
main body
bifurcation
upstream
arteria
graft prosthesis
Prior art date
Application number
PCT/DK1994/000468
Other languages
English (en)
Inventor
Dierk Vorwerk
Rolf W. GÜNTHER
Thomas Schmitz-Rode
Original Assignee
William Cook Europe A/S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by William Cook Europe A/S filed Critical William Cook Europe A/S
Priority to DE69416604T priority Critical patent/DE69416604T2/de
Priority to AU12719/95A priority patent/AU678331C/en
Priority to JP51647495A priority patent/JP3555763B2/ja
Priority to DK95903769T priority patent/DK0734235T3/da
Priority to US08/446,761 priority patent/US5562724A/en
Priority to EP95903769A priority patent/EP0734235B1/fr
Priority to PL94315028A priority patent/PL176348B1/pl
Publication of WO1995016406A1 publication Critical patent/WO1995016406A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/001—Figure-8-shaped, e.g. hourglass-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped

Definitions

  • An endovascular graft prosthesis and an implantation method for such a prosthesis are provided.
  • the invention relates to an endovascular graft prosthesis for arrangement at or in the vicinity of a bifurcation in the arterial system of a patient and comprising a substantially tubular main body for location in an upstream arteria above the bifurcation and substantially tubular legs joining said main body and extending via the bifurcation into each of two downstream branch arteries, said main body being made of a flexible microporous and surgically implantable woven material unpenetratable to blood.
  • the invention is concerned with the repair of an aneurysm in the vicinity of the aortic bifurcation, but it may also be applied to other parts of the arterial system where a principal upstream arteria bifurcates into two branch arteries.
  • An aortic aneurysm may develop as a result of a reduction of the strength of the aortic wall whereby the diameter of the affected part of the aorta may increase to more than 5 cm. Such expansions may result in flow irregularities and promotion of deposits of coagulated blood in the affected region. At increased expansion the remaining strength of the aortic wall will naturally decrease and may ultimately result in rupture of the vessel with an inherent danger of acute bleeding.
  • bifurcated graft prosthesis which may be transluminarly implanted for the repair of an aneurysm at or in the vicinity of the aortic bifurcation.
  • the bifurcated prosthesis is made as an integral unit with a main body and two tubular legs joining the main body in a bifurcation.
  • an endovascular graft prosthesis is characterized in that the main body is substantially bag-shaped with an open proximal upstream end and a distal downstream bottom region in which two outlet openings are provided, said main body being radially expandable and attachable in a radially expanded condition to the inner side of said upstream arteria upstream of the bifurcation by fixation means, said legs being made as separate resilient and radially expandable leg stent devices adapted for introduction in a collapsed condition through said branch arteries and into said outlet openings, each of said stent devices being engageable in its radially expanded condition against the rim of the corresponding outlet opening to provide a leakage- free bifurcated graft prosthesis.
  • the prosthesis By making up the prosthesis from a number of separate components which may be sequentially introduced in the arterial system by percutaneous operations through small openings with a punctual diameter up to 5 mm the components may be endovascularly assembled to a complete prosthesis after deployment in the actual vascular section. Thereby, the prosthesis according to the invention may also be applied for repair of an aneurysm extending into the iliac arteries.
  • the invention further relates to a method for implanting an endovascular graft prosthesis for deployment at or in the vicinity, a bifurcation in the arterial, system of a patient and associated branch arteries.”
  • this method is characterized by the steps of introducing through a first branch arteria in an upstream direction by means of a first guide wire a separate, radially expandable and substantially bag shaped main body into an upstream arteria to extend into a region thereof above the bifurcation, said main body having an open proximal upstream end with associated fixation means and a distal downstream bottom region in which two outlet openings are provided, expanding said main body radially in said upstream arteria with said proximal end attached to the wall thereof, and introducing by means of said further guide wires a radially expandable leg stent device through each of the branch arteries into each of said outlet openings.
  • the main body consisting of a micro porous woven material unpenetratable to blood may be guided by means of a guide wire from a puncture in an iliac arteria into the aorta and deployed there with a downstream orientation of the distal bottom region of the body with respect to the blood flow direction.
  • the guide wire will be coaxially located in one or both of the outlet openings of the bag-shaped body.
  • the main body will be sufficiently expanded by the blood flow in its bottom region.
  • the main body is secured to the inner wall of the aorta upstream of the bifurcation by means of a radially expandable stent device which may typically be a self-expandable metallic stent.
  • leg stent device may be introduced over each guide wire to extend at least through the distance between the bottom region of the main body and the junction of the iliac arteries.
  • the leg stent devices forming separate components of the prosthesis may have an elastic covering over their entire length and are also radially expandable.
  • the introduction of the two leg stent devices which may also be self-expandable metallic stents may take place by use of conventional catheter technique whereby the guide wire and the catheter are guided from one outlet opening through the other and into the opposite iliac arteria from where it may be guided in a conventional way through the vessel to the skin.
  • the position of the main body may still be corrected.
  • two catheters may be introduced into the outlet openings over the guide wire thus positioned from the two groins to allow coaxial introduction of two guide wires to replace the two catheters.
  • the two leg stents covered by woven material are introduced over the positioned guide wires which can take place simultaneously for both stent devices.
  • the two leg stents will press against the rim of the outlet openings and complete the main body into a leakage free endovascular prosthesis with a bifurcation secured in the aorta.
  • the main stent is attached to the bag- shaped main body with the downstream distal end overlapped by the upstream proximal end of the main body.
  • the endovascular deployment of the prosthesis may be substantially facilitated if the main stent device and the leg stent devices in a manner known per se are formed ' by self-expandable metal stents.
  • each outlet opening may diverge in the downstream direction.
  • each outlet opening close to the inner side of the bottom region of the bag-shaped main body a radially inwardly projecting opening rim against which the external side of the leg stent may engage tightly whereby the security against leakage will be increased.
  • each of the leg stents may be 2-4 mm greater than the minimum rim diameter of each outlet opening.
  • fig. 1 shows a bag-shaped main body of a prosthesis according to the invention deployed in expanded condition within an aortic aneurysm
  • fig. 2 illustrates the introduction of two guide wires into the main body of fig. 1 and fig. 3 the main body completed with two leg stents into a prosthesis with a bifurcation.
  • figures 1 to 3 illustrate schematically an arterial system 1 in which the abdominal part of the aorta 2 extending between two branch arteries 3,4 leading to the kidneys and a bifurcation joining two iliac arteries 5,6 has been damaged by a balloon shaped aneurysm 7.
  • a bag-shaped main body made of a micro-porous woven material unpenetratable to blood is first introduced in the region of the aneurysm 7 in the aorta 2, said main body being formed in a bottom region with two outlet openings 9,10.
  • the main body 8 is provided with a self-expandable metallic stent 11 and is introduced in contracted condition through an iliac arteria 5 over a guide wire 12 and deployed in the aorta 2 in such a way that the metallic stent 11 will press at least the upper edge of the main body 8 tightly against the inner side of the aorta 2 above the aneurysm 7.
  • the guide wire 12 may as shown in dashed lines in fig.
  • a self- expandable metallic stent 15,16 with an elastic covering may now be introduced in a conventional way.
  • a proximal end part of each of the metallic stents 15,16 projects into the interior of the main body whereas a distal end part of each metallic stent projects relatively deep into the iliac arteria 5,6.
  • the metallic stents 15,16 are contracted in the rim region of each of outlet openings 9 and 10 and will thereby be firmly and tightly connected with the main body 8.
  • the main body together with the leg stents 15 and 16 will form an endovascular aortic prosthesis overlapping the aneurysm 7 and being implaritable by relatively simple percutaneous operations.

Abstract

Une prothèse pour greffe endovasculaire, destinée à être placée au niveau d'une bifurcation du système artériel d'un patient, ou dans la région d'une telle bifurcation, notamment pour réparer un anévrisme ou la bifurcation aortique, comprend un corps principal essentiellement tubulaire se plaçant dans l'artère principale en amont de la bifurcation, telle que celle de l'aorte, ainsi que des branches essentiellement tubulaires réunies audit corps principal dans une bifurcation et s'étendant dans chacune des deux branches artérielles telles que les artères iliaques. Le corps principal (8) est généralement en forme de sac, avec une extrémité proximale ouverte en amont et une région inférieure distale en aval, dans laquelle deux ouvertures de sortie (9,10) sont prévues, ledit corps principal se fixant au côté interne de l'artère principale (2) par l'intermédiaire d'un extenseur apte à s'élargir (11). Les branches sont fabriquées sous forme d'extenseurs séparés, aptes à s'élargir (15, 16), qui peuvent être introduits sous une forme affaissée à travers les artères et dans les ouvertures de sortie (9, 10) du corps principal par l'intermédiaire de fils de guidage (13, 14) de sorte qu'ils entrent en contact avec le bord de l'ouverture de sortie correspondante afin de constituer une prothèse bifurquée à l'épreuve des fuites.
PCT/DK1994/000468 1993-12-15 1994-12-15 Prothese pour greffe endovasculaire et procede d'implantation WO1995016406A1 (fr)

Priority Applications (7)

Application Number Priority Date Filing Date Title
DE69416604T DE69416604T2 (de) 1993-12-15 1994-12-15 Endovaskuläres transplantat und kit zum implantieren eines solchen transplantats
AU12719/95A AU678331C (en) 1993-12-15 1994-12-15 An endovascular graft prosthesis and an implantation method for such a prosthesis
JP51647495A JP3555763B2 (ja) 1993-12-15 1994-12-15 血管内移植用補綴材料及び血管内移植用補綴材料を備えた移植装置
DK95903769T DK0734235T3 (da) 1993-12-15 1994-12-15 Endovaskulær graftprotese og kit til implantation af en sådan protese
US08/446,761 US5562724A (en) 1993-12-15 1994-12-15 Endovascular graft prosthesis and an implantation method for such a prosthesis
EP95903769A EP0734235B1 (fr) 1993-12-15 1994-12-15 Prothese pour greffe endovasculaire et ensemble pour l'implantation
PL94315028A PL176348B1 (pl) 1993-12-15 1994-12-15 Wszczepialna proteza wewnątrznaczyniowa

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DEG9319267.3U 1993-12-15
DE9319267U DE9319267U1 (de) 1993-12-15 1993-12-15 Aortenendoprothese

Publications (1)

Publication Number Publication Date
WO1995016406A1 true WO1995016406A1 (fr) 1995-06-22

Family

ID=6902030

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DK1994/000468 WO1995016406A1 (fr) 1993-12-15 1994-12-15 Prothese pour greffe endovasculaire et procede d'implantation

Country Status (10)

Country Link
US (1) US5562724A (fr)
EP (1) EP0734235B1 (fr)
JP (1) JP3555763B2 (fr)
CZ (1) CZ284329B6 (fr)
DE (2) DE9319267U1 (fr)
DK (1) DK0734235T3 (fr)
ES (1) ES2129799T3 (fr)
PL (1) PL176348B1 (fr)
RU (1) RU2118138C1 (fr)
WO (1) WO1995016406A1 (fr)

Cited By (45)

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WO1998007389A1 (fr) 1996-08-19 1998-02-26 Cook Incorporated Appareillage prothetique endovasculaire, et procede d'utilisation
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Publication number Publication date
EP0734235B1 (fr) 1999-02-17
JP3555763B2 (ja) 2004-08-18
US5562724A (en) 1996-10-08
PL315028A1 (en) 1996-09-30
AU678331B2 (en) 1997-05-22
CZ284329B6 (cs) 1998-10-14
RU2118138C1 (ru) 1998-08-27
DE9319267U1 (de) 1994-02-24
DE69416604D1 (de) 1999-03-25
EP0734235A1 (fr) 1996-10-02
CZ172896A3 (en) 1997-06-11
PL176348B1 (pl) 1999-05-31
DK0734235T3 (da) 1999-09-20
AU1271995A (en) 1995-07-03
JPH09506524A (ja) 1997-06-30
ES2129799T3 (es) 1999-06-16
DE69416604T2 (de) 1999-09-30

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